Electronic stimulation device, method of treatment and electronic stimulation system

ABSTRACT

An electronic stimulation device is adapted for electrically stimulating a target zone of an organism with relative low pain sensations without generating relative much sensations of paresthesia. The electronic stimulation device comprises at least one electronic stimulation unit. The electronic stimulation unit includes at least one first electrode and at least one second electrode. The electronic stimulation unit receives a high-frequency electrical stimulation signal to impel the first electrode and the second electrode to generate an electric field. The range of the electric field covers the target zone, and the electric field strength ranges from 100 V/m to 1000 V/m. The frequency of the high-frequency electrical stimulation signal ranges from 200 KHz to 1000 KHz.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a Continuation-In-Part of U.S. application Ser. No.14/049,235 filed on Oct. 9, 2013.

BACKGROUND

1. Technical Field

The invention relates to an electronic stimulation device, in particularto an electronic stimulation device for electrically stimulating atarget zone of an organism with relative low pain sensations withoutgenerating relative much sensations of paresthesia.

2. Related Art

The human nerve system provides transmission paths for the commandsissued from the brain. The human nerve has a threshold and the thresholdis often reduced around a damaged spot of the nerve. Therefore,uncomfortable pain or ache is frequently and easily felt at this spot.After a period of time, this spot would become a source of chronic pain.

Clinically, an approach called Continuous Radiofrequency (CRF) orRadiofrequency Ablation is widely applied to ease various nerve pains.The approach inserts a pin into the proximity of related nerve tissue,applies continuous high-frequency signal to create high temperature soas to destroy the nerve tissue, thereby alleviating the nerve pain.However, due to the human body's self-repair function, the destroyednerve tissue will try to heal itself When this happens, newly developedtissue grows randomly on the destroyed tissue, and it is quite commonthat a neuroma is formed. The neuroma, once formed, often oppresses thenerve system and causes even more serious pain.

SUMMARY

An electronic stimulation device is adapted for electrically stimulatinga target zone of an organism with relative low pain sensations withoutgenerating relative much sensations of paresthesia. The electronicstimulation device comprises at least one electronic stimulation unit.The electronic stimulation unit includes at least one first electrodeand at least one second electrode. The electronic stimulation unitreceives a high-frequency electrical stimulation signal to impel thefirst electrode and the second electrode to generate an electric field.The range of the electric field covers the target zone, and the electricfield strength ranges from 100 V/m to 1000 V/m. The frequency of thehigh-frequency electrical stimulation signal ranges from 200 KHz to 1000KHz.

In one embodiment, the high-frequency electrical stimulation signal is apulse signal and its pulse frequency ranges from 0 to 1 KHz.

In one embodiment, the frequency of the high-frequency electricalstimulation signal ranges from 200 KHz to 450 KHz or ranges from 550 KHzto 1000 KHz.

In one embodiment, the voltage of the high-frequency electricalstimulation signal ranges from −10V to −1V or ranges from 1V to 10V.

In one embodiment, the current of the high-frequency electricalstimulation signal ranges from 2 mA to 50 mA.

In one embodiment, the distance from the first electrode to the secondelectrode ranges from 1 mm to 7 mm, and the distance between the firstelectrode, the second electrode and the target zone ranges from 0 to 10mm.

In one embodiment, the high-frequency electrical stimulation signal isadapted to block the neurotransmission in the target zone.

In one embodiment, the target zone is brain, vertebral column, dorsalroot ganglion and/or spinal dorsal horn.

In one embodiment, the electronic stimulation unit receives alow-frequency electrical stimulation signal, and the frequency of thelow-frequency electrical stimulation signal is less than 1 KHz.

A method of treatment is applied to electrically stimulate a target zoneof an organism by a stimulation device with relative low pain sensationswithout generating relative much sensations of paresthesia. Thestimulation device includes an electronic stimulation unit including atleast one first electrode and at least one second electrode. The methodcomprises: placing the electronic stimulation unit near the target zone;delivering a high-frequency electrical stimulation signal by theelectronic stimulation unit; generating an electric field covering thetarget zone by the first electrode and the second electrode, wherein theelectric field strength ranges from 100 V/m to 1000 V/m; andelectrically stimulating the target zone. The frequency of thehigh-frequency electrical stimulation signal ranges from 200 KHz to 1000KHz.

In one embodiment, the high-frequency electrical stimulation signal is apulse signal and its pulse frequency ranges from 0 to 1 KHz.

In one embodiment, the frequency of the high-frequency electricalstimulation signal ranges from 200 KHz to 450 KHz or ranges from 550 KHzto 1000

In one embodiment, the voltage of the high-frequency electricalstimulation signal ranges from −10V to −1V or ranges from 1V to 10V.

In one embodiment, the current of the high-frequency electricalstimulation signal ranges from 2 mA to 50 mA.

In one embodiment, the high-frequency electrical stimulation signal isused by the electronic stimulation device to block the neurotransmissionin the target zone.

In one embodiment, the target zone is brain, vertebral column, dorsalroot ganglion and/or spinal dorsal horn.

An electronic stimulation system comprises a control unit and anelectronic stimulation device. The electronic stimulation devicecomprises at least one electronic stimulation unit including at leastone first electrode and at least one second electrode. The controllerdirects the electronic stimulation unit to deliver a high-frequencyelectrical stimulation signal to impel the first electrode and thesecond electrode to generate an electric field. The range of theelectric field covers the target zone and the electric field strengthranges from 100 V/m to 1000 V/m for electrically stimulating the targetzone. The frequency of the high-frequency electrical stimulation signalranges from 200 KHz to 1000 KHz.

In one embodiment, the frequency of the high-frequency electricalstimulation signal ranges from 200 KHz to 450 KHz or ranges from 550 KHzto 1000 KHz.

In one embodiment, the voltage of the high-frequency electricalstimulation signal ranges from −10V to −1V or ranges from 1V to 10V.

In one embodiment, the current of the high-frequency electricalstimulation signal ranges from 2 mA to 50 mA.

BRIEF DESCRIPTION OF THE DRAWINGS

The embodiments will become more fully understood from the detaileddescription and accompanying drawings, which are given for illustrationonly, and thus are not limitative of the present invention, and wherein:

FIG. 1A is a schematic diagram showing the electronic stimulation deviceapplied to the dorsal root ganglion according to the first embodiment;

FIG. 1B is a circuit block diagram of the electronic stimulation deviceand the controller in FIG. 1A;

FIG. 1C is a schematic diagram showing the pulse signal of theelectrical stimulation signal of the electronic stimulation device inFIG. 1;

FIG. 2A and 2B are enlarged diagrams showing a portion of the electronicstimulation unit in FIG. 1;

FIG. 3A to 3E and FIG. 4A to 4E are schematic diagrams of the electricfield simulation of the electronic stimulation device;

FIG. 5A and FIG. 5B are schematic diagrams of the electric fieldsimulation at the condition that the electronic stimulation deviceoperates at different electrode intervals and different frequencies ofthe electrical stimulation signals;

FIG. 6 is another schematic diagram showing the electronic stimulationdevice in FIG. 1A;

FIG. 7 to FIG. 8 are schematic diagrams showing another examples of theelectronic stimulation device according to other embodiments;

FIG. 9 to FIG. 14 are schematic diagrams showing another examples of theelectronic stimulation device;

FIG. 15 is a schematic diagrams showing the application of highstimulation device according to an embodiment;

FIG. 16 showing the result of the pain behavior test on the foot in therat -Von Frey (VF); and

FIG. 17A and FIG. 17B respectively showing the results of the controlgroup and the experimental group of neuroelectrophysiological test.

DETAILED DESCRIPTION OF THE INVENTION

The embodiments of the invention will be apparent from the followingdetailed description, which proceeds with reference to the accompanyingdrawings, wherein the same references relate to the same elements.

FIG. 1A is a schematic diagram showing the electronic stimulation deviceapplied to the dorsal root ganglion according to the first embodiment.Referring to FIG. 1A, an electronic stimulation device 1 is applied toelectrically stimulate a target zone of an organism. In the embodiment,the target zone is dorsal root ganglion 3 for example. Alternatively,the target zone may be for example but not limited to brain, vertebralcolumn, and/or spinal dorsal horn of an organism. The vertebral columnmay be T9 vertebrae or T10 vertebrae for example. The followingparagraphs will describe the elements and applications of the electronicstimulation device 1.

For the sake of clarity regarding the step details of the method, thecircuits and interaction of the electronic stimulation device 1 and thecontroller 2 are explained first in the following paragraphs. Then, thefollowing paragraphs describe electrically stimulating the target zoneof the organism by the electronic stimulation device 1 of theembodiment. However, the descriptions in the following embodiments areexemplary but not intended to limit the scope of the invention.

FIG. 1B is a circuit block diagram of the electronic stimulation deviceand the controller in FIG. 1A. Referring to FIG. 1B, a controller 2provides configuration parameters and supplies energy for the electronicstimulation device 1. Because the controller 2 does not need to beimplanted in the organism, it may be called the external controller 2.Elements of the electronic stimulation device 1 and the controller 2 andtheir relationships will be described in the following paragraphs.

In the embodiment, the electronic stimulation device 1 includes a firstcontrol unit 11 and an electronic stimulation unit 12. The electronicstimulation unit 12 is coupled to the first control unit 11. Thecontroller 2 includes a second control unit 21, a human-computerinterface 22 and a power supply unit 23. The human-computer interface 22is coupled to the second control unit 21. The power supply unit 23 isalso coupled to the second control unit 21 and acts as the power sourceof the controller 2. The power supply unit 23 may be a battery or arechargeable battery, or it may be a power adapter connected to mainselectricity to supply electrical power.

In the embodiment, the user may use the human-computer interface 22 tooperate the controller 2. Before beginning, the system default values ofthe controller 2 is initialized. Then, he may also use thehuman-computer interface 22 to input the required configurationparameters to the second control unit 21. In the embodiment, thehuman-computer interface 22 may be for example but not limited to touchbutton, touch panel, physical button or their combination. The secondcontrol unit 21 instructs the power supply unit 23 to supply DC power tothe elements of the electronic stimulation device 1 (for example theelectronic stimulation unit 12) to operate.

The first control unit 11 and the second control unit 21 may beimplemented with digital circuit such as IC or implemented with analogcircuit. For example, IC may be a micro-processor, a MCU, a programmablelogic gate array (for example FPGA or CPLD) or ASIC. In the embodiment,it is a MCU for example but not limited thereto.

In the embodiment, the electronic stimulation device 1 is an implantableelectronic stimulation device for example. The implantable electronicstimulation device means that at least one portion of the element of theelectronic stimulation device 1 is implanted in the individual body (forexample: subcutaneous). Moreover, the electronic stimulation device 1may be changed to a transcutaneous electronic stimulation devicedepending on the symptom and requirement of the patient. In theembodiment, the electronic stimulation unit 12 is adapted to beimplanted in the individual. The first control unit 11 may be implantedwithin the individual or disposed outside the individual depending onactual or design requirement. If the electronic stimulation unit 12 isprepared to be implanted into one individual, it is better to implantthe device in near the dorsal root ganglion of the spinal nerve relevantto the patient's pain. The individual preferably is an organism, and itmay include mammals such as mouse, human, rabbit, cattle, sheep, pig,monkey, dog, cat, etc. Preferably, it is human. For example, it ishuman.

As to the configuration of the electronic stimulation unit 12, referringto FIG. 1A and FIG. 2B, the electronic stimulation unit 12 comprises aflexible transmission lead including at least one first electrode 121and at least one second electrode 122. In the embodiment, it includes apair of electrodes, namely a positive electrode 121 and a negativeelectrode 122 for example. In addition, there are maybe two pairs, threepairs or more than three pairs of electrodes of the electronicstimulation unit 12, and they may be evenly distributed on thetransmission lead, namely the electronic stimulation unit 12. The aboveelectrodes operate in bipolar mode to generate an electric field betweenthe first electrode 121 and the second electrode 122. In the embodiment,between the first electrode 121 and the second electrode, there arecoils or wires formed from winding coaxial conductor which areelectrically connected to the electrodes. For example, the material ofthe first electrode 121 and the second electrode 122 may be metal forexample platinum, silver, gold or other conductive metal. Between thefirst electrode 121 and the second electrode 122, a zone is defined bythe coils or wires which are compactly wound cable electricallyconnected to the electrodes. The first electrode 121 and the secondelectrode 122 are disposed at one end of the electronic stimulation unit12, two contacts 123 acting as the positive and negative electrodes aredisposed at the other end of the electronic stimulation unit 12. The twocontacts 123 are electrically connected or coupled to the first controlunit 11. The first electrode 121 and the second electrode 122 arerespectively linked to compactly wound coils, and they are linked to thecontacts 123 through the wires. Besides, the wires of the electronicstimulation unit 12 beyond the first electrode 121 and the secondelectrode 122 is covered by an insulator 120. In FIG.2A, the insulator120 is removed to show the coil disposed between the electrodes in theelectronic stimulation unit 12.

The range of the individual length a of each electrode depends on actualor design requirement. The electrode length a is between 0.5˜6 mm,preferably between 1˜4 mm. The individual length a of the firstelectrode 121 and the second electrode 122 means that the length of theelectrode in the direction parallel to the extension direction of themajor axis of the cable of the electronic stimulation unit 12 on thecondition that it is not implanted and the electronic stimulation unit12 is horizontally spread. The range of the individual length a of thefirst electrode 121 and the second electrode 122 depends on actual ordesign requirement. For example, the length a is between 1˜3 mm. Thedistance b between the first electrode 121 and the second electrode 122is between 1˜7 mm, preferably between 1˜4 mm. For example, the distanceb of the two adjacent ends of the adjacent first and second electrodes121,122 is preferably between 1˜4 mm.

A second interval distance c exists between the first electrode 121 andthe second electrode 122 of the electronic stimulation unit 1 and thedorsal root ganglion 3. The second interval distance c is defined as theshortest distance from the midpoint of the adjacent first and secondelectrodes 121, 122 to the dorsal root ganglion 3. In the embodiment,the second interval distance c ranges from 0 to 10 mm, preferably from 0to 5 mm. If the distance c is 0, the midpoint of the first electrode 121and the second electrode 122 in the projection direction overlaps thedorsal root ganglion 3.

Referring to FIG. 1C, in the embodiment, the electrical stimulationsignal outputted from the electronic stimulation device 1 may be acontinuous sine wave, a continuous triangle wave or an electricalstimulation signal of high-frequency pulse. If it is an electricalstimulation pulse signal, one pulse cycle time Tp has a plurality ofpulse signals and at least one period of rest time. One pulse cycle timeis the reciprocal of pulse repetition frequency. The pulse repetitionfrequency (also called pulse frequency) is between 0˜1 KHz, preferablybetween 1˜100 Hz. In the embodiment, the pulse repetition frequency ofthe electrical stimulation signal is about 2 Hz. Besides, the durationtime Td of pulses in one pulse cycle time is between 1˜250 ms,preferably between 10˜100 ms. In the embodiment it is 25 ms for example.

Referring to FIG. 1C, in the embodiment, the electronic stimulation unit12 is adapted to transmit a high-frequency electrical stimulationsignal. For example, the patient (or healthcare workers) uses thecontroller 2 to set the electrical stimulation frequency, stimulationperiod, stimulation intensity and/or other parameters of thehigh-frequency electrical stimulation signal. Then, the controller 2outputs the parameters and energy to the electronic stimulation device1, and directs the electronic stimulation unit 1 to output signal viathe first control unit 11. In the embodiment, the frequency of thehigh-frequency electrical stimulation signal is about 600 KHz. In otherwords, its stimulation cycle time Ts is about 1.67 ms.

For example, the electronic stimulation device may be chosen to bedriven in a constant voltage mode or a constant current mode. Theconstant voltage mode is safer than the constant current mode, but theintensity in the constant voltage mode is less stable than in theconstant current mode. Choosing which mode depends on the target zone tobe electrically stimulated. For example, if the target is dorsal column,the constant current mode is chosen. If the target is the dorsal rootganglion, the constant voltage mode is chosen. When the constant voltagemode is chosen for driving, the voltage of the high-frequency electricalstimulation signal is constant, and the current of the high-frequencyelectrical stimulation signal varies with the positions and resistancesof the first electrode 121 and the second electrode 122. Otherwise, whenthe constant current mode is chosen for driving, the current of thehigh-frequency electrical stimulation signal is constant, and thevoltage of the high-frequency electrical stimulation signal varies withthe positions and resistances of the first electrode 121 and the secondelectrode 122. For example, in the constant voltage mode, the voltage ofthe high-frequency electrical stimulation signal ranges from −10V to −1Vor from 1V to 10V. Preferably, the voltage of the high-frequencyelectrical stimulation signal ranges from 10V to −3 V or from 3V to 10V.In the constant current mode, the current of the high-frequencyelectrical stimulation signal ranges from 2 mA to 50 mA, preferably from4 ma to 30 mA.

Besides, the frequency of the high-frequency electrical stimulationsignal is between 200 KHZ˜1000 KHz, preferably between 200 KHz˜250 KHz,250 KHz˜350 KHz, 350 KHz˜450 KHz, 450 KHz˜550 KHz, 550 KHz˜650 KHz, 650KHz˜750 KHz, 750 KHz˜800 KHz, or 800 KHz˜1000 KHz. If the selectedfrequency is between 200 KHz˜450 KHz, the device operates in relativelylow frequency so it is less risky to produce biological heat for bettersafety. Otherwise, if /the selected frequency is between 550 KHz˜1000KHz, the generated electric field has greater density so its electricalstimulation has better performance. In addition, by adjusting theduration time Td, the amount of the electrical stimulation is adjustedand the time for dissipating the produced biological heat accordingly.For example, if the stimulation intensity is relatively low, theduration time Td may be increased to continuously stimulate. If thestimulation intensity and the frequency are relatively high, theduration time Td may be decreased to raise the time for dissipating.

When the electronic stimulation unit 12 receives the high-frequencyelectrical stimulation signal, the first electrode 121 and the secondelectrode 122 of the electronic stimulation unit 12 accordingly generatean electric field. The distance from the first electrode 121 and thesecond electrode 122 to the dorsal root ganglion 3 is arranged withinthe range of the second interval distance c, so the electric fieldgenerated by the first electrode 121 and the second electrode 122 coversthe dorsal root ganglion 3. In other words, the electric field coversthe dorsal root ganglion 3 and its surroundings to electricallystimulate the target dorsal root ganglion 3 with low intensity, lowtemperature and high frequency. Without destroying the neural cells ofthe dorsal root ganglion 3, the biomolecule generation by the dorsalroot ganglion 3 is suppressed ‘ and the threshold of the target zone ofthe dorsal root ganglion 3 is also raised. Thus, the neurotransmissioncapability of the dorsal root ganglion 3 in the target zone is loweredand the neurotransmission is blocked. As a result, the patient feelsnerve pain as little as possible.

Furthermore, the patient may feel as little as possible pain on thetarget zone without generating relative much sensations of paresthesiaif applying the electronic stimulation device for electricalstimulation. The patient suffering pains over a long period of time mayaccept this electrical stimulation treatment which is effective andgenerates as little as possible sensations of paresthesia. Preferably,the treatment resulting from the electrical stimulation by theelectronic stimulation device in the embodiment may keep effective aboutone week. In other words, the neurotransmission is blocked about oneweek. Thus, the patient may less frequently receive the electricalstimulation treatment and it is not necessary for him to receive thetreatment frequently so he may be more possibly willing to receive thetreatment. Because the details can refer to the later experimentalexamples, they are not repeated here.

Furthermore, referring to FIG. 3A to FIG. 3D, the field pattern of theelectric field is adjusted by adjusting the electrode length a of thefirst electrode 121 and the second electrode 122, the first intervaldistance b between the first electrode 121 and the second electrode 122,or the second interval distance c between the first electrode 121, thesecond electrode 122 and the dorsal root ganglion 3. For example, thevoltage of the electrical stimulation signal is 5V, its frequency is 500KHz, and the distance C is 5 mm. Assuming that the electrode length aand the distance c of the first electrode 121 and the second electrode122 are constant (a=1 mm, c=5 mm), as smaller the distance b (b=2 mm)between the first electrode 121 and the second electrode 122 as shown inthe electric field simulation diagram in FIG. 3, the electric field (thestrength of the electric field is 100V/m˜1000V/m) may only or mainlyeffectively cover the dorsal root ganglion 3 to be stimulated; asgreater the distance b (b=4 mm) between the first electrode 121 and thesecond electrode 122 as shown in FIG. 3B, the field pattern of theelectric field is distributed expandingly and completely cover thedorsal root ganglion 3 to be stimulated (the drawn strength of theelectric field is 100V/m˜1000V/m). Relatively, the electric fieldstrength is more intensive if the position is closer to theelectromagnetic field of the first electrode 121 and the secondelectrode 122. As shown in FIG. 3C, it is a distribution diagram of thefield pattern that the field pattern of the electric field in FIG. 3A isapplied with a more intensive electric field so the strength of theelectric field is distributed in the range 100V/m˜5000V/m. From thefigure, as long as the electrode is disposed close enough to the targetzone which is to be stimulated (the distance c is between 0˜10 mm), theelectric field has an effect on it and the electric field with higherintensity is distributed more closer to the surface of the electrode.Then, referring to FIG. 3D and FIG. 3E, the difference between FIG. 3Dand FIG. 3C is the electrode length a of the first electrode 121 and thesecond electrode 122. In FIG. 3D, the electrode length a is changed to 2mm. From FIG. 3D, it is seen that the electrode becomes longer and thespace distribution of the field pattern of the electric field alsobecomes slightly larger. The difference between FIG. 3E and FIG. 3D isthat the distance b between the electrodes is changed to 6 mm on thecondition that the electrode length a of the first electrode 121 and thesecond electrode 122 are both fixed (at 2 mm) As the distance b betweenthe electrodes is increased, the space distribution of the field patternof the electric field also becomes larger.

Then, different voltage influences on the space distribution of thefield pattern of the electric field are compared. Referring to FIG. 4Ato FIG. 4C, the frequency 500 KHz of the constant electrical stimulationsignal is applied, and the electrode length a of the first electrode 121and the second electrode 122, the distance b between the electrodes andthe distance c to the target zone to be stimulated are all fixed (a=2mm, b=2 mm, c=5 mm) Different voltage influences on the spacedistribution of the field pattern of the electric field are shown in thefigures (the voltage is 3V in FIG. 4A, the voltage is 5V in FIG. 4B, thevoltage is 10V in FIG. 4C). From the figures, it is seen that as thevoltage is greater, the space distribution of the field pattern of theelectric field also becomes larger.

Then, comparing FIG. 4B, FIG. 4D and FIG. 4E, the electrical stimulationsignal with 5V is applied, and the electrode length a of the firstelectrode 121 and the second electrode 122, the distance b between theelectrodes, and the distance c to the target zone to be stimulated areall fixed (a=2 mm, b=2 mm, c=5 mm) Different frequency influences of theelectrical stimulation signal on the space distribution of the fieldpattern of the electric field are shown in the figures (the frequency ofthe electrical stimulation signal is 200 KHz in FIG. 4D, the frequencyof the electrical stimulation signal is 500 KHz in FIG. 4B, thefrequency of the electrical stimulation signal is 800 KHz in FIG. 4E).From FIG. 5B, because around the arc length at 4 mm it is the pointclosest to the electronic stimulation unit, the most intensive strengthof the electric field is here. As the frequency is increased, the spacedistribution of the field pattern of the electric field also becomeslarger. From FIG. 3A to FIG. 4E, in the embodiment, the electric fieldstrength ranges from 100 V/m to 5000 V/m, preferably from 400 V/m to5000 V/m.

Referring to FIG. 5A and FIG. 5B, the diameter of the target (circulardorsal root ganglion 3) to be stimulated also shown in FIG. 2B is 5 mm,the electrode length a of the first electrode 121 and the secondelectrode 122 is about 1 mm, the distance c is about 5 mm and the inputvoltage is 5V. The electric field strength on the target to bestimulated for different arc length location of the electrode (in thehorizontal axis, the tangent at the left side of the circle is taken asthe start point of the arc 0 mm) is shown in the figures. In FIG. 5A,the corresponding strength of the electric field is detected atdifferent frequencies (200 KHz, 600 KHz and 1000 KHz) for electricstimulation are compared. In FIG. 5B, the corresponding strength of theelectric field is detected at different distances b between electrodes(b is 2, 3, 4, 5, or 6 mm.) From FIG. 5A, as the frequency of theelectric stimulation signal is increased, the strength of the electricfield is more intensive and the space distribution of the field patternof the electric field also becomes larger. For example, under thecondition that the frequency of the electric stimulation signal is 1000KHz, the maximum strength of the electric field at the target zone mayreach 400 V/m. Under the condition that the frequency of the electricstimulation signal is 200 KHz, the maximum strength of the electricfield at the target zone may be not intensive enough to reach 300 V/m.From FIG. 5B, if the distance b is between 4 mm˜6 mm, the electric fieldstrength of the electromagnetic field reaches its maximum.

After the electronic stimulation unit 12 is implanted in the organism,to utilize it as fully as possible, the electronic stimulation device 1of the embodiment is able to operate in a low-frequency mode to assistthe doctor in checking whether the electrodes are at correct positionsafter the implantation. For example, in the low-frequency mode, theelectronic stimulation unit 12 may deliver a low-frequency electricalstimulation signal of which the frequency is between 0.1 Hz˜1 KHz andits pulse width is between 10 μs˜500 μs. The electronic stimulation unit12 delivers the low-frequency electrical stimulation signal to detectthe corresponding spasm of the muscle so as to check whether theimplanted electronic stimulation unit is loose or at wrong positions.

Referring to FIG. 2A and FIG. 6, in the embodiment, the electronicstimulation unit 12 is like a straight line, but it is not limitedthereto. The shape of the electronic stimulation unit 12 may be like theshape described in the following embodiments, but it is not limitedthereto.

In the embodiment, the electronic stimulation device 1 is an activeelectronic stimulation device of which the first control unit 11together with the electronic stimulation unit 12 are implanted in thetarget zone of the organism. In other words, both the first control unit11 and the electronic stimulation unit 12 are implanted in the organismsubcutaneously. Alternatively, the first control unit 11 and theelectronic stimulation unit 12 are integrated into one part first andthen implanted subcutaneously. Because of electrically coupled to thecontroller 2 outside the organism, the first control unit 11 can receivethe parameter signal and energy from the second control unit 21 so theelectronic stimulation unit 12 may electrically stimulate the targetzone of the organism.

The electronic stimulation device of the disclosure is not limited tothe electronic stimulation device 1 mentioned above. In otherembodiment, the active electronic stimulation device may be like theelectronic stimulation device in FIG. 7. The electronic stimulationdevice 1 a in the embodiment and the electronic stimulation device 1 inthe previous embodiment have substantially alike elements thereof, andthe first control unit 11 a and the electronic stimulation unit 12 a arealso respectively implanted in the epidermis S of the organism(subcutaneous). However in the embodiment, the first control unit 11 aof the electronic stimulation device 1 a is a FPCB (flexible printedcircuit board) integrated in the electronic stimulation unit, and itstill can receive the parameter signal and electrical energy from thesecond control unit (not shown in the figure) outside the organism, anddeliver the electrical stimulation signal to the electronic stimulationunit 12 a to electrically stimulate the dorsal root ganglion 3 of theorganism. In the embodiment, the electronic stimulation device 1 a maybe narrowed enough to be implanted subcutaneously for abating the burdenof the organism (or the patient).

Alternatively, the electronic stimulation device may be like the deviceshown in FIG. 8. Referring to FIG. 8, in the embodiment, the electronicstimulation device 1 b is a passive electronic stimulation device.However, the first control unit 11 b of the electronic stimulationdevice 1 b is integrated in the controller 2 outside the epidermis S ofthe organism (subcutaneous). Thus, the implanted electronic stimulationdevice 1 b does not contain the control unit therein. The electronicstimulation unit 11 b (lead) at its end has a FPCB which is implantedsubcutaneously and not deeply (for example the depth is less than 5 cm).The controller 2 b which is not implanted within the skin can deliver anelectrical stimulation signal to the electronic stimulation unit 11 b,so the electronic stimulation unit 12 b can electrically stimulate thedorsal root ganglion 3 of the organism.

As to implementation of the electronic stimulation unit, it is notlimited to the above electronic stimulation unit 12. FIGS. 9, 12, 13illustrate another embodiment. In the embodiment, the electronicstimulation unit 12 c is like a ring, and the electronic stimulationunit 12 c includes at least two first electrodes 121 and at least twosecond electrodes 122. The first electrodes 121 and the second electrode122 are interlaced at intervals (as shown in FIG. 12). Alternatively,the first electrodes 121 and the second electrodes 122 may be arrangedsequentially without interlacement (as shown in FIG. 13). The electricfield generated by the first electrode 121 and the second electrode 122of the electronic stimulation unit 12 surrounds and covers the targetdorsal root ganglion 3 (as shown in FIG. 14) to stimulate it with lowintensity, low temperature and high frequency electromagnetism.Furthermore, if the position is closer to the first electrode 121 andthe second electrode 122, the electric field is more intensive.

Referring to FIG. 10, the electronic stimulation unit 12 d may be like ahelix, and the electronic stimulation unit 12 d includes at least twofirst electrodes 121 and at least two second electrodes 122. In theembodiment, the electronic stimulation unit 12 d includes two firstelectrodes 121 and two second electrodes 122 for example. Thearrangement of the first electrode 121 and the second electrode 122 isnot limited. The first electrodes 121 and the second electrodes 122 maybe interlaced or arranged without interlacement, and the firstelectrodes 121 and the second electrodes 122 may be arranged like ahelix to surround the dorsal root ganglion 3. Because the electric fieldgenerated by the first electrodes 121 and the second electrodes 122 likea helix surround and cover the target dorsal root ganglion 3, the targetdorsal root ganglion 3 is electrically stimulated with low intensity,low temperature and high frequency.

Referring to FIG. 11, in the embodiment, the electronic stimulation unit12 e is like an arc, and the electronic stimulation unit 12 e includesat least two first electrodes 121 and at least two second electrodes122. In the embodiment, the electronic stimulation unit 12 e includestwo first electrodes 121 and two second electrodes 122 for example. Thearrangement of the first electrodes 121 and the second electrodes 122 isnot limited. The first electrodes 121 and the second electrodes 122 maybe interlaced or arranged without interlacement, and the firstelectrodes 121 and the second electrodes 122 may be arranged to surroundthe dorsal root ganglion 3. Because the electric field generated by thefirst electrode 121 and the second electrode 122 surround and cover thedorsal root ganglion 3, the target dorsal root ganglion 3 is stimulatedwith low intensity, low temperature and high frequency.

Referring to FIG. 15, in the embodiment, the electronic stimulation unit12 f is like a flake (or a flat), and the electronic stimulation unit 12f includes a plurality of the first electrodes 121 and a plurality ofthe second electrodes 122. These first electrodes 121 and these secondelectrodes 122 are arranged at intervals in an array. Similarly, theelectric field generated by the first electrode 121 and the secondelectrode 122 surrounds and covers the dorsal root ganglion 3 so as toelectrically stimulate the target, the dorsal root ganglion 3, with lowintensity and low temperature.

From the below experiments, the operation and effect of the electronicstimulation device which stimulates the dorsal root ganglion areexplained. However, the below examples are just explanatory but notlimited to the scope of the invention.

EXPERIMENTAL EXAMPLE 1 The Pain Behavior Test on the Foot in the Rat—VonFrey (VF) Test

Sprague-Dawley rats (SD rats) of about 275-350 grams weight are used(BioLASCO, Taiwan co., Ltd., Taiwan) and they are provided from thecentral laboratory animal center of Shin Kong Wu Ho-Su MemorialHospital. The spinal nerve ligation (SNL) is performed on the L5 spinalnerve of the SD rat. After the development of the pain behavior isstable for few days and conforms to the clinical pain development model,the electronic stimulation unit 1 is implanted and then thehigh-frequency electrical stimulation therapy is performed. In thisexperimental example, the rats are divided into the control group (N=3)and the experimental group (N=7) according to the different electricalstimulation treatments. As to the experimental group, the pain behavioris continuously observed for 7 days after surgery. After the painbehavior is stable, the high-frequency electrical stimulation therapy isperformed for 5 minutes once a week totally three times, and theresponses to the pain behavior tests are observed. The results are shownin FIG. 16.

As shown in FIG. 16, the pain behavior of the control group becomesstable on the third day until the 29th day, and Von Frey pain pressurethresholds are all less than 5 g (between 1.72±0.39 g and 4.85±1.31 g).As to the experimental group, its pain behavior is similar to that ofthe control group before receiving high-frequency electrical stimulationtherapy (on the 7th day, D7) and becomes stable on about the third daysimilarly. However, after receiving the first (D7) high-frequencyelectrical stimulation, its Von Frey pain pressure thresholds areimproved. They are different from the control group (D8: 4.73±1.47 g;D10: 4.85±1.31 g) both on D8 (9.85±1.56 g) and D10 (9.0±1.68 g), thetolerance levels of the pressure thresholds in the experimental groupare improved up to about 10 g, the pain pressure thresholds increase toabout 2.08 times as compared with the control group, and the pain reliefwill gradually decay until receiving the second high-frequencyelectrical stimulation therapy (the experimental group D14: 4.53±1.08 g;the control group D14: 2.98±1.44 g). On the next day after receiving thesecond (D14) high-frequency electrical stimulation therapy (theexperimental group D15: 8.12±1.65 g; the control group D15: 1.81±0.53 g;the pain pressure threshold of the experimental group is about 4.49times greater than that of the control group), the therapy of receivingthe first high-frequency electrical stimulation is still effective. Theresponse to the pain behavior test is still excellent on the next dayafter receiving the third (D21) high-frequency electrical stimulationtherapy (the experimental group D22: 9.17±1.93 g; the control group D22:2.73±0.57 g; the pain pressure threshold of the experimental group isabout 3.36 times greater than that of the control group). Obviously, thepain can be immediately relieved, and there are differences of the painpressure thresholds between the experimental group and the control groupevery time after receiving the high-frequency electrical stimulationtherapy. It approves that after the electrical stimulation unit of theinvention is implanted, receiving the high-frequency electricalstimulation therapy for 5 minutes once a week can relieve the pain for ashort time.

EXPERIMENTAL EXAMPLE 2 Neuroelectrophysiological Test

SD rats are divided into the experimental group and the control group,the experimental group (FIG. 17B) receives the high-frequency electricalstimulation for 5 minutes, and the control group (FIG. 17A) does notreceive any electrical stimulation. The two groups receive large currentstimulation (2.5T, C response threshold) on the sciatic nerve under thesame conditions so as to induce obvious A responses (referring toA-fiber) and C responses (referring to C-fiber) occurring in theipsilateral spinal dorsal horn. Before the interventional measure(high-frequency electrical stimulation for 5 minutes or suspendingrecording for 5 minutes), the baseline is measured for 30 minutes (18samples, 100 seconds interval) in advance. After the interventionalmeasure is provided, the large current stimulation is performed on thesciatic nerve once every 30 minutes, the data are continuously recordedfor 2 hours, and 5 experimental waveforms are respectively generated intwo groups. The results of the control group and the experimental groupare respectively shown in FIG. 17A and FIG. 17B.

In this experiment, as to the rats receiving the high-frequencyelectrical stimulation for 5 minutes, the mean values of the neuralresponses for every 30 minutes are aligned at the point of 90 ms first,and then the individual time of each group are compared. Referring toFIG. 17A and FIG. 17B, the mean lines of interval of every 30 minutesare put together for comparison. Here, there are no significantdifferences between the curves of individual time in the control groupshown in FIG. 17A. Compared with the control group, it can be seen fromFIG. 17B that the C-component is relatively largely reduced after thehigh-frequency electrical stimulation in comparison with the baseline inthe experimental group.

In detail, the large current stimulation on the peripheral sciatic nerveacts as the source of pain in this experimental example, and the signalcan be transmitted to the dorsal root ganglion and the spinal dorsalroot nerves through A-fibers and C-fibers by nerve conduction. Theneural response to the interventional measure of high-frequencyelectrical stimulation can be observed by electrophysiologicalmeasurement of nerve conduction. From FIG. 17B, the induced C responseis relatively largely reduced with time after receiving thehigh-frequency electrical stimulation, and the area of the C-component(intensity) is also reduced with time. It shows that the axon of theC-fiber which is responsible for sense of pain (especially the painwhich is chronic and difficult to locate) is changed in transmission.The high-frequency electrical stimulation blocks or inhibits the signaltransmission of neuron in some fibers, so the pain can be relieved, eventotally blocked.

Although the invention has been described with reference to specificembodiments, this description is not meant to be construed in a limitingsense. Various modifications of the disclosed embodiments, as well asalternative embodiments, will be apparent to persons skilled in the art.It is, therefore, contemplated that the appended claims will cover allmodifications that fall within the true scope of the invention.

What is claimed is:
 1. An electronic stimulation device for electricallystimulating a target zone of an organism with relative low painsensations without generating relative much sensations of paresthesia,comprising: at least one electronic stimulation unit including at leastone first electrode and at least one second electrode, wherein theelectronic stimulation unit delivers a high-frequency electricalstimulation signal to impel the first electrode and the second electrodeto generate an electric field, the range of the electric field coversthe target zone, and the electric field strength ranges from 100 V/m to1000 V/m, wherein the frequency of the high-frequency electricalstimulation signal ranges from 200 KHz to 1000 KHz.
 2. The electronicstimulation device according to claim 1, wherein the high-frequencyelectrical stimulation signal is a pulse signal and its pulse frequencyranges from 0 to 1 KHz.
 3. The electronic stimulation device accordingto claim 1, wherein the frequency of the high-frequency electricalstimulation signal ranges from 200 KHz to 450 KHz or ranges from 550 KHzto 1000 KHz.
 4. The electronic stimulation device according to claim 1,wherein the voltage of the high-frequency electrical stimulation signalranges from −10V to −1V or ranges from 1V to 10V.
 5. The electronicstimulation device according to claim 1, wherein the current of thehigh-frequency electrical stimulation signal ranges from 2 mA to 50 mA.6. The electronic stimulation device according to claim 1, wherein thedistance from the first electrode to the second electrode ranges from 1mm to 7 mm, and the distance between the first electrode, the secondelectrode and the target zone ranges from 0 to 10 mm.
 7. The electronicstimulation device according to claim 1, wherein the high-frequencyelectrical stimulation signal is adapted to block the neurotransmissionin the target zone.
 8. The electronic stimulation device according toclaim 1, wherein the target zone is brain, vertebral column, dorsal rootganglion and/or spinal dorsal horn.
 9. The electronic stimulation deviceaccording to claim 1, wherein the electronic stimulation unit receives alow-frequency electrical stimulation signal, and the frequency of thelow-frequency electrical stimulation signal is less than 1 KHz.
 10. Amethod of treatment applied to electrically stimulate a target zone ofan organism by a stimulation device with relative low pain sensationswithout generating relative much sensations of paresthesia, wherein thestimulation device includes an electronic stimulation unit including atleast one first electrode and at least one second electrode, comprising:placing the electronic stimulation unit near the target zone; deliveringa high-frequency electrical stimulation signal by the electronicstimulation unit; generating an electric field covering the target zoneby the first electrode and the second electrode, wherein the electricfield strength ranges from 100 V/m to 1000 V/m; and electricallystimulating the target zone; wherein the frequency of the high-frequencyelectrical stimulation signal ranges from 200 KHz to 1000 KHz.
 11. Themethod according to claim 10, wherein the high-frequency electricalstimulation signal is a pulse signal and its pulse frequency ranges from0 to 1 KHz.
 12. The method according to claim 10, wherein the frequencyof the high-frequency electrical stimulation signal ranges from 200 KHzto 450 KHz or ranges from 550 KHz to 1000 KHz.
 13. The method accordingto claim 10, wherein the voltage of the high-frequency electricalstimulation signal ranges from −10V to −1V or ranges from 1V to 10V. 14.The method according to claim 10, wherein the current of thehigh-frequency electrical stimulation signal ranges from 2 mA to 50 mA.15. The method according to claim 10, wherein the high-frequencyelectrical stimulation signal is used by the electronic stimulationdevice to block the neurotransmission in the target zone.
 16. The methodaccording to claim 10, wherein the target zone is brain, vertebralcolumn, dorsal root ganglion and/or spinal dorsal horn.
 17. Anelectronic stimulation system, comprising: a control unit; and anelectronic stimulation device comprising at least one electronicstimulation unit including at least one first electrode and at least onesecond electrode, wherein the controller directs the electronicstimulation unit to deliver a high-frequency electrical stimulationsignal to impel the first electrode and the second electrode to generatean electric field, the range of the electric field covers the targetzone and the electric field strength ranges from 100 V/m to 1000 V/m forelectrically stimulating the target zone, wherein the frequency of thehigh-frequency electrical stimulation signal ranges from 200 KHz to 1000KHz.
 18. The electronic stimulation system according to claim 17,wherein the frequency of the high-frequency electrical stimulationsignal ranges from 200 KHz to 450 KHz or ranges from 550 KHz to 1000KHz.
 19. The electronic stimulation system according to claim 17,wherein the voltage of the high-frequency electrical stimulation signalranges from −10V to −1V or ranges from 1V to 10V.
 20. The electronicstimulation system according to claim 17, wherein the current of thehigh-frequency electrical stimulation signal ranges from 2 mA to 50 mA.